OBJECTIVES: Recurrent urinary tract infection (rUTI), affecting over 100 million people globally each year, is associated with significant symptom morbidity and quality of life (QoL) impact. This study developed and validated the first rUTI-specific patient-reported outcome measures (PROMs): the Recurrent UTI Symptom Scale (RUTISS) and the Recurrent UTI Impact Questionnaire (RUTIIQ).

METHODS: A five-stage PROM development methodology concordant with the FDA and COSMIN guidelines enabled iterative refinement. (I) Concept elicitation was informed by a literature review and qualitative framework analysis of patient experiences (N=1983), building initial questionnaire items. (II) A two-stage Delphi methodology was applied to gain expert rUTI clinician (N=15) consensus on item relevance and clarity. (III) 28 people living with rUTI participated in one-to-one cognitive interviews, providing feedback on items’ comprehensibility and comprehensiveness. (IV) 240 people living with rUTI completed the PROMs in an online pilot survey, facilitating exploratory psychometric analysis and item refinement. (V) A validation survey completed by 389 people living with rUTI allowed confirmatory structural validity testing and final item refinement.

RESULTS: The 15-item RUTISS assesses UTI symptom frequency, global change in symptoms, and severity of four symptom domains: urinary symptoms, urinary presentation, UTI pain and discomfort, and bodily sensations. The 18-item RUTIIQ evaluates five QoL domains: personal wellbeing, social wellbeing, work and activity interference, patient satisfaction, and sexual wellbeing. Both PROMs demonstrate strong psychometric properties, with excellent model fit and structural validity (RMSEA<.06, CFI>.95, SRMSR<.06), content validity (I-CVI>.75), construct validity (Spearman’s ρ>.60), internal consistency (Cronbach’s α>.80), and readability (US 6th grade).

CONCLUSIONS: The RUTISS and the RUTIIQ are psychometrically robust PROMs capable of dynamically assessing the patient perspective of rUTI symptoms and QoL impact. These brief measures deliver the unique opportunity to critically inform and enhance the quality of rUTI healthcare, facilitating patient-centred care via standardised evaluation of key patient-reported outcomes and prioritisation of the rUTI patient perspective.